Last Updated November 20, 2020

Valsartan has experienced widespread adoption and been a popular drug since its introduction in the 1990s. It is typically prescribed alone or in conjunction with other medications to combat high blood pressure. It is also considered a “second choice” treatment for patients who have not enjoyed success with other drugs such as ACE inhibitors such as ramipril or lisinopril.

The FDA has recalled some batches of generic Valsartan due to fears over contamination with N-Nitrosodimethylamine (NDMA), a potent carcinogen. It is believed that the contamination resulted from poor quality control practices at factories in India and China. The complete list of recalled batches and manufacturers can be found here.

Valsartan Pregnancy Warning

The FDA classifies Valsartan as a “Category D” medication, meaning there is “positive evidence” of human fetal risk based on adverse reaction data from investigations. Accordingly, Valsartan’s label comes with a prominent black box warning concerning pregnancy and fetal toxicity. The use of drugs like Valsartan can reduce fetal renal function and increase the chances of fetal death. Women who learn they are pregnant should discontinue the use of Valsartan as soon as possible.

Common Side Effects of Valsartan

Studies of Valsartan have revealed the following side effects which tend to occur in 1 or more out of 100 people taking the medication:

• Dizziness/Spinning (vertigo)
• Headaches
• Nausea
• Vomiting and diarrhea
• Joint/Muscle Pain

Liver Damage

Through its post-marketing analysis, the FDA has received reporting from drug manufacturers and physicians potentially linking Valsartan with acute liver injuries, impairment of liver function, and elevated enzymes. Symptoms will typically start to manifest one to eight weeks after starting the use of Valsartan. Patients who experience the following symptoms should contact their physician for further review:

• Jaundice
• Itchy Skin
• Chronic Fatigue
• Dark Urine
• Irregular Stool Color
• Abdominal Pain/Swelling
• Easily Bruising

Valsartan FDA Recall and Cancer Risk

In 2018, the FDA began a series of voluntary recalls following random tests of generic Valsartan which revealed NDMA contamination. NDMA is considered to be an extremely potent carcinogen.

The cancer risk associated with NDMA in Valsartan must be understood in combination with other risk factors such as genetic predisposition; environment; smoking; drinking and eating habits; and obesity. However, researchers theorize that long-term exposure to NDMA could be linked with the following cancers:

The FDA offered some perspective on the risk associated with contaminated Valsartan. In its updated announcement, the agency estimated that if 8,000 patients took 320mg of valsartan (the highest dose) contaminated with NDMA, there may be one additional cancer case during the lifetimes of those patients. The estimate is based upon average impurity levels in a single tablet of valsartan.

Tracy Everhart

Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.